GE NM/CT 860 system Model Number H3908AD - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Serial numbers: 860Y62016, 860Y62019, 860Y62017, 860Z62032, 860Y62018, 860Y62015, 860Y62012, 860Y62020, 860Y62021, 860Y62013, 860Z62033, 860Z62031
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- GE Healthcare, LLC
- Reason for Recall:
- GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
GE NM/CT 860 system Model Number H3908AD - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.
Product Codes/Lot Numbers:
Serial numbers: 860Y62016, 860Y62019, 860Y62017, 860Z62032, 860Y62018, 860Y62015, 860Y62012, 860Y62020, 860Y62021, 860Y62013, 860Z62033, 860Z62031
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0854-2021
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